[18F]HX4 PET/CT Imaging for Detection of Hypoxia

Lung Cancer Clinical Trial

— OXYPET  

Official title:

A Phase II, Single Centre Exploratory Study of [18F]HX4 PET/CT Imaging to Detect Hypoxia in Patients With Head and Neck and Lung Cancer, Receiving Radiotherapy With Curative Intent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976883
• Other study ID #: 13MP003
• Status: Completed
• Phase: Phase 2
• Start date: March 31, 2015
• Est. completion date: July 25, 2017

Study information

• Verified date: January 2019
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up data will be collected from routine appointments, and analysed with the hypoxia scan results to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 25, 2017
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with:

1. biopsy proven non-small cell carcinoma of the lung >2.5 cm in size with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent or

2. squamous cell carcinoma of the upper aerodigestive tract with a primary tumour or nodal mass >2. 5 cm in size, with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent.

• Participant must be willing and able to give informed consent for participation in the study.

• Patients must be 18 years old or above.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

• Have normal renal function, defined by creatinine clearance of >60 mL/min.

• Able to remain still in the supine position on the scanner bed for the 40 minute duration of the examination.

• Able (in the Investigators opinion) and willing to comply with all study requirements.

• Willing to allow his or her General Practitioner and hospital consultant, if appropriate, to be notified of participation in the study

Exclusion criteria

• Patients who are scheduled for surgery prior to radiotherapy will not be included.

• Female participant who is pregnant, lactating or planning pregnancy during the course of the study.

• Chronic kidney disease stage III or worse, as defined by the NKF clinical practice guidelines (GFR <60 mL/min per 1.73 m3 for 3 months or more).

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of involvement in the study, or may influence the result of the study, or the participant's ability to participate in the study.

• Participants who have been involved in another research study involving an investigational product in the past 12 weeks.

• Previous surgery or radiotherapy to the upper aerodigestive tract or lung, which in the opinion of the Investigators could compromise the data.

• Previous cancer diagnosis.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypoxia
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• [18F]HX4 diagnostic PET/CT scan
Single intravenous injection of [18F]HX4 and PET/CT scan

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy		2 years
Secondary	Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.		5 years
Secondary	Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images		5 years